JP4444282B2 - Inflatable spherical spinal graft - Google Patents

Abstract

A prosthetic implant for forming a support structure between adjoining vertebrae in a spinal column. The prosthetic implant includes a generally spherical or ellipsoidal body that at least partially engages a surface of adjacent vertebrae.

Description

  The present invention relates to an artificial implant, and more particularly to an intervertebral spinal prosthesis for fusing two or more vertebrae together, more precisely to an intervertebral disc. It relates to an intervertebral spinal prosthesis which is an alternative and / or a spacer between two vertebrae.

  This application claims priority to co-pending US Provisional Patent Application No. 60 / 455,875, filed Mar. 20, 2003, “Banded Spherical Spine Graft”.

  US Provisional Patent Application No. 60 / 455,875 filed Mar. 20, 2003 “Banded Spherical Spine Graft” is incorporated herein by reference. Also, US Pat. No. 6,478,822 “Spherical Spine Graft” is incorporated herein by reference.

  The human spine is composed of columns consisting of over 30 bones and structures that connect them. The vertebra closer to the head is known as the anterior sacral vertebra, which consists of separate bones that can be individually moved. These vertebral bodies are connected by anterior and posterior ligaments and a fibrocartilage disc commonly known as an intervertebral disc. These discs are located between opposing faces of adjacent vertebral bodies. A column consisting of the vertebrae and the intervertebral disc forms the central axis that supports the head and trunk. These vertebrae also surround a hole through which the spinal cord passes.

  The anterior sacral vertebra is generally held in place by an intervertebral disc, ligament, and body muscle tissue. These vertebrae move relative to adjacent vertebrae, allowing the head to be rotated relative to the body and providing a wide range of flexibility with respect to the spine.

  One of the most costly health problems is back pain as well as spinal lesions. Such a problem affects each individual regardless of age, and as a result, such a person is seriously troubled. Back pain is caused by several factors. These factors include congenital malformations, traumatic injury, and degenerative changes to the spine. Congenital malformations, traumatic injuries, or degenerative changes to the spine result in pain when overly moved, the motor segment collapses, the spinal canal becomes smaller, nerve structures are compressed, debilitating pain, Paralysis and other problems can occur, which in turn cause nerve root compression or spinal stenosis.

  Impaired nerve conduction may be related to the intervertebral disc or the vertebra itself. Such symptoms include disc herniation, where a small amount of tissue protrudes into the hole from both sides of the disc and compresses the spinal cord. The second common symptom is the formation of small osteophytes called bone growth along the posterior surface of the vertebral body, which also impairs the spinal cord.

  Once the symptoms are identified, a surgical procedure is required to correct the problem site. One surgical procedure taken against the above problems associated with the formation of spinal or herniated discs is a discectomy. This procedure exposes the relevant vertebrae and removes the intervertebral disc, thus removing the disturbing tissue or providing an access path for removing osteophytes. Next, a second procedure called spinal fusion must be performed to secure the vertebrae together so that they do not move and maintain the space originally occupied by the intervertebral disc. Although this procedure detracts from the flexibility of the spine, a slight loss of mobility is generally acceptable due to the relatively large number of vertebrae.

  During spinal fusion after discectomy, a spinal prosthesis is inserted into the intervertebral space. This artificial graft is often a bone graft taken from another body part of the patient, called an autograft. Although using bone taken from the patient's body is very effective in avoiding artificial graft rejection, there are several drawbacks. There is always a risk in opening the second surgical site to obtain the graft. For example, opening a second surgical site may result in infection or pain in the patient and / or loss of bone material that may weaken the site and cause other damage. . The bone used to form the artificial graft may not be perfectly shaped and / or placed, causing graft displacement and resorption and / or fusion of the bone graft and vertebrae. May fail.

  Another option as a graft source of material for an artificial graft is bone taken from a cadaver called an allograft, or bone taken from another species called a xenograft. This has the advantage of not having to open the second surgical site, but increases the problems associated with graft rejection and the risk of infectious diseases.

  An alternative approach to forming an artificial graft using bone from a patient or other source is to make the artificial graft from a synthetic material that is biocompatible with the body and vertebrae. A wide variety of compositions and geometries of such artificial implants have been used, but the results have varied. The shape of the artificial graft varies from a simple mass of material to a carefully shaped artificial graft.

  An acceptable artificial graft that can be used to replace the intervertebral disc and maintain the stability of the intervertebral disc space between adjacent vertebrae, at least until complete arthrodesis is achieved. Attempts to develop are increasing. The artificial implant takes various forms. Various types of synthetic prosthetic devices have been proposed, but the success rate is low, the surgical procedure is complicated and often causes trauma to the patient. Some of these artificial implants are designed to strike the disc space and the vertebral endplate. Other artificial implants have been developed that have a non-constant cross section or a spherical shape.

  The various artificial grafts that have been developed can generally be divided into two basic types: solid grafts and grafts designed to promote bone ingrowth. Artificial implants that promote the natural ingrowth of bones provide faster and more stable joint fixation. These artificial implants are usually filled with the original bone before being inserted into the disc space. These prosthetic grafts typically have a hole in communication with the opening in the prosthetic graft, which causes tissue to grow between the vertebral endplate and the bone or bone substitute in the prosthetic graft. It provides a route for When an artificial graft to be fused with the vertebra is selected, the disc space for the artificial graft is usually pretreated by cutting the vertebra endplate to a bleeding state to allow tissue growth on the artificial graft. I try to encourage them.

  Many prosthetic grafts available at the present time still have various problems. To achieve fusion, hollow implants that allow bone ingrowth within bones or bone substitutes in artificial implants are recognized as the best technique, but most of these devices are at least Without any additional stabilization system (eg, cage, rod, screw, nail, post, plate, etc.), it is difficult to achieve the desired amount of fusion. In addition, some artificial implants lack sufficient structural strength to support the most frequent fusion spine levels, primarily the lower lumbar spine.

  In view of the current state of the art on artificial implants, the normal vertebrae of the instrumentation target part have sufficient strength to support the vertebrae until they are optimized, optimizing the bone ingrowth capability as needed There is a continuing need for new prosthetic implant designs that maintain or reduce anatomy and / or reduce the misalignment when inserted between vertebrae to eliminate the occurrence of nerve compression.

  The present invention relates to an improved implant, and more specifically, an improved artificial implant for insertion between one or more vertebrae, and one or more of the artificial implants. It relates to a method for inserting between further vertebrae.

In accordance with certain aspects of the present invention, the artificial implant is used to at least partially support the adjacent vertebrae of the spinal column. The artificial implant includes a generally spherical or ellipsoidal body and at least one inflatable element. The at least one inflatable element may be a portion of the body of a substantially spherical or ellipsoidal or may be a separate entity from the main body of substantially spherical or ellipsoid. The at least one inflatable element can be used to at least partially form at least one stabilizer. The at least one stabilizer can be inflated to a generally disc shape or some other shape. At least one inflatable element includes at least one bioactive substance. The at least one bioactive agent may be coated on the at least one inflatable element and / or may be contained within the at least one inflatable element. At least a portion of the at least one inflatable element may or may not be a substantially smooth surface. The radial width during expansion of the at least one inflatable element may be substantially constant or variable. The expanded thickness of the at least one expandable element may be substantially constant or variable. The at least one inflatable element can expand radially outward from the generally spherical or ellipsoidal body , along a substantially constant axis, or at an offset therefrom. At least one inflatable element includes at least one tapered edge in the inflated state. The at least one inflatable element and the generally spherical or ellipsoidal body can be formed of the same material or of different materials. The substantially spherical or ellipsoidal body may include a portion of the plurality of portions. When the substantially spherical or ellipsoidal body includes a plurality of parts, the parts may have the same or different shapes, dimensions, structures, compositions, and the like. At least one inflatable element may include an elastic material at least prior to expansion. This elastic material may be formed and / or contained within an inflatable sac (bag). The material that at least partially forms the expandable material may be at least partially curable. Body of substantially spherical or ellipsoid, along at least two parts of the body of the spherical or ellipsoidal may include mechanical compression devices designed to compress at least partially. The generally spherical or ellipsoidal body may include a shape memory material. The substantially spherical or ellipsoidal body may include at least one electrical connection. The substantially spherical or ellipsoidal body may include at least one pressure sensor.

According to another and / or alternative aspect of the present invention, the artificial implant is designed in a generally spherical or ellipsoidal shape (such as an oval shape) manufactured as either a one-part or multi-part structure. Includes fabricated body. Although an artificial graft is basically designed to be inserted between two vertebrae, the concepts associated with this artificial graft can also be used for other body regions. This artificial implant is designed to at least partially mimic the space between two vertebrae. Artificial grafts are designed to provide improved spinal support fixation and methodologies that provide stability between adjacent vertebrae and facilitate their fixation between vertebrae by their shape. This artificial graft is designed to be easily and efficiently placed between two vertebrae and to reduce the failure rate of the artificial graft between vertebrae. The prosthetic graft includes one or more surfaces that reduce compression of the spinal cord and other parts proximate to the prosthetic graft. Artificial implants consist of two hemispherical parts, with a central core small core at the center and a formable material module in one or more mechanisms in various shapes (eg, torus, donut, etc.) ) Can be inflated. The prosthetic implant includes two hemispheres connected to a central element that expands into a stabilizer. The inflatable intermediate portion of the artificial implant (eg, torus type, cylindrical element, etc.) is at an angle (vertical, 0.01-89.90 °, 90.01-179. 99 °) or the like, or may be designed to be inflatable to form a circumferential edge with respect to the inflated element. The expansion of the intermediate section is, but is not limited to, inflating by the use of fluid pressure that intentionally initiates expansion by electrical stimulation and / or chemical reaction (e.g. Or by injecting into another part to induce expansion, such as activating a pump on and / or in an artificial implant to induce expansion), using shape memory metals and / or polymers to induce expansion Inducing expansion using the force applied to the prosthesis by the vertebrae, inducing expansion by clamping one or more ends of the prosthesis, and / or in the prosthesis Can be done by one or more mechanisms, such as turning a screw or placing a mechanical element to induce expansion, or activating a motor on and / or in an artificial implant to induce expansion . The intermediate portion can be designed to expand by a set amount or a variable amount. Middle section, from the outer surface of the body of spherical or ellipsoidal artificial grafts, expands by about 0.01% -300% of the length of the diameter of the body of spherical or ellipsoidal, surgeon and size of the lesion vertebral It is designed so that the most appropriate shape for insertion into the disc space can be selected based on the position. The angle of articulation of the intermediate portion upon expansion relative to the surface of the spherical or ellipsoidal body varies within an angle range of at least about 0.01 ° to about 180 °. The intermediate portion may be designed to expand uniformly across its lateral boundaries, and one or more portions of the intermediate portion may expand while one or more other portions may be in their original positions. It may be designed so that the amount of expansion stays or is different. The intermediate portion may be designed such that the angle of expansion is uniform or designed so that one or more portions have a different angle of expansion than one or more other portions. Also good. The intermediate portion may be designed such that the thickness and / or contour of the intermediate portion when inflated is uniform, or one or more portions are different from one or more other portions. It may be designed to have a thickness and / or contour. The prosthetic implant may include one or more threaded internal cavities that can be used to receive a threaded rod to facilitate insertion of the prosthetic graft between vertebrae. A threaded “plug” or cap is used to at least partially close or seal the screw hole during and / or after the prosthesis is properly positioned between the two vertebrae. . The artificial implant is designed to receive one or more bone growth materials and / or agents that are at least partially filled into one or more cavities and / or channels of the artificial implant. Yes. The filling of one or more cavities and / or channels can be performed before, during and / or after insertion of the prosthesis between vertebrae. Alternatively or additionally, filling of one or more cavities and / or channels may be performed after a surgical procedure (eg, in an endoscopic procedure, etc.). After the filler is inserted, a “plug” or cap can be used to at least partially cover or seal one or more cavities and / or channels. The one or more plugs prevent or prevent bone growth / extension into the one or more cavities and / or openings so that the thin thread of the growing bone has one or more cavities and / or openings. It has also been used to reduce or prevent penetration, and the thin threads of this growing bone tend to break and form jagged edges and floating bone fragments. The artificial implant may include tracking markers that can be visualized, such as with some other electromagnetic inspection, such as in X-ray film, MRI images, ultrasonography, and / or other types of sonography. . The tracking marker can be placed on and / or in the prosthesis to provide the surgeon with a way to monitor the position and / or movement of the implant. Various prosthetic implants can be fabricated with varying body and / or ballast radial dimensions so that the correct size prosthesis can be selected for insertion between two specific vertebrae. it can. An artificial graft is coated with one or more materials on its outer surface to promote and / or enhance bone growth, prevent artificial graft rejection, and promote healing in and / or around the artificial graft. And / or drugs and / or other bioactive substances can be delivered around the artificial implant. Several examples of coating materials include, but are not limited to: (i) polymer-based or other bone cement, (ii) foamed polymer or urethane foam, (iii) epoxy, (iv) self-derived growth compounds, Powdered bone, or another suitable biological agent compound, and / or (v) a pharmaceutical agent that relieves pain and / or promotes bone growth. The artificial implant may be designed to have a smooth polished outer surface. Artificial implants may be designed such that one or more regions of the outer surface are formed with a concave, frosted, and / or roughened or non-smooth outer surface with grooves or channels on the outer surface. You may cut it. The prosthetic graft may include one or more non-smooth surfaces to facilitate securing the prosthesis in place between the vertebrae. The artificial graft has one or more channels or cavities that are filled before, during and / or after insertion of the artificial graft and / or outside one or more portions of the artificial graft. Covering and facilitating and / or facilitating the introduction of pain relieving drugs, promoting healing, preventing rejection, increasing flexibility, increasing rigidity, and / or one or more May serve other useful purposes. The artificial implant may include a bioabsorbable material or a non-bioabsorbable material. When the artificial graft contains a bioabsorbable material, the bioabsorbable material is decomposed and absorbed, so that the mechanism or a designated portion thereof is decomposed and absorbed into the body during a predetermined period. The artificial implant may be at least partially coated with a bioactive material to promote bone growth and / or to enhance anchorage of the anchor in the bone. The artificial graft may be at least partially coated with a bioresistive material to inhibit bone growth and / or resist the spinal graft from being anchored within the bone. A special set of tools can also be designed for use with the artificial implant to facilitate insertion of the spinal implant. Artificial implants are typically spinal vertebrae to support the vertebrae to be repaired or partially or wholly removed spinal discs during the course of a surgical procedure where one artificial substitute is utilized. It is designed to be inserted into the space between two vertebrae created by removing all or part of the disc. Before, after, and / or during the insertion of the artificial graft, the artificial graft expands the middle part to increase or stabilize the artificial graft, and the stabilizer functions during the healing process. I am doing so. Typically, the artificial implant is inserted at a location where it can avoid moving into or extending out of the spinal column while simultaneously avoiding entry into the spinal cord region. Artificial implants can be made of and include various materials including, but not limited to, sterilized and shaped bone (human and / or mammal), polymeric materials, biocompatible carbon fibers Bone pseudo- and / or bone equivalent materials, reinforced polymers, conventional orthopedic implant materials (eg, titanium, chromium cobalt, stainless steel, etc.) and / or degradable absorbable materials. The prosthetic implant is formed, at least in part, from a material that approximates the elasticity of the vertebrae and / or discs.

  The present invention takes the physical form of certain components and component arrangements, and its preferred embodiments are described and illustrated in detail with reference to the accompanying drawings, which are a part of this application.

  The contents of the drawings are only for the purpose of illustrating a preferred embodiment of the present invention and are not intended to limit the present invention. FIG. 1 illustrates the intervertebral disc space between the two vertebrae of the spinal column. 1 shows a prosthesis or implant 10 designed to be inserted. The artificial implant 10 is shown as having a spherical body 20 having an outer surface 22. As can be appreciated, the body 20 may have other shapes. The spherical body 20 can be formed of a variety of materials including, but not limited to, bone, stainless steel, titanium, chromium molybdenum, cobalt chromium alloy, ceramic (zirconium oxide ceramic, aluminum oxide ceramic, etc.) , Chromium or chromium alloy, cobalt or cobalt alloy, polycarbonate, polypropylene, polyethylene, polymethyl methacrylate, glass and / or carbon fiber filled polysorbone, and various carbon and fiber reinforced polymers. The particular material selected will generally depend on the location of the implant and the purpose to be achieved with the implant. The spherical body 20 may be one or more bioactive substances and / or bioneutral substances (eg, drugs, bone and / or tissue growth promoters, bones) that are mixed with or become the material of the spherical body 20. And / or tissue growth inhibitor, cement, etc.). Using one or more bioactive substances and / or bioneutral substances to escape or escape from the spherical body 20 and enter the bone, tissue, and / or fluid surrounding the prosthesis, and And / or can be reacted with bone, tissue, and / or fluid surrounding the prosthetic implant and / or one or more bioactive and / or bioneutral substances on the spherical body and / or Alternatively, it may be held inside.

  The artificial graft is formed of a biocompatible material for use in humans, but the artificial graft is one or more compatible with other vertebrates (eg, dogs, cats, horses, etc.). You may form with a material. The artificial implant is sized and dimensioned to be inserted at least partially between the two vertebrae. The prosthetic implant is designed to be placed at least partially within the intervertebral disc space previously occupied by at least a portion of the intervertebral disc. The intervertebral disc is partially or completely removed prior to inserting the artificial graft between the vertebrae. Artificial implants are designed to be easily inserted by established surgical procedures and / or designed to reduce or minimize as much as possible the difficulty of surgical procedures. The geometry of the prosthesis facilitates obtaining good and / or desired load bearing and / or support through the vertebra, and allows the prosthesis to be displaced relative to the vertebra during surgical and / or post-operative procedures. Selected to reduce sex and / or suppress as much as possible. The artificial implant can achieve arthrodesis (fusion) and / or arthroplasty between adjacent vertebrae, depending on the desired procedure. Thus, the surgeon can use this artificial joint to form either a multi-directional joint or a fusion between two or more vertebrae. Artificial implants are designed, at least in part, to reduce or eliminate nerve compression due to damaged or removed discs.

Now, as shown in FIG. 1, the prosthetic implant 10 includes a spherical body 20 having an outer surface 22 that is substantially smoothly drawn, although it will be appreciated that the body may be any other shape. In addition, and / or the outer surface may include one or more non-smooth surfaces. The maximum radius of the generally spherical or ellipsoidal body depends on the position of the artificial implant between the specific vertebrae. Typically, the maximum radius of a generally spherical or ellipsoidal body used for adult humans varies from about 2 to 20 mm, although other radii may be used. Maximum radius of the body of substantially spherical or ellipsoid body of substantially spherical or ellipsoid, between the vertebrae, which are arranged at least partially in the two adjacent, as well as the surrounding forming the remainder of the spinal structural fibers And so that it can be placed between muscles. The maximum radius of the generally spherical or ellipsoidal body is selected such that two adjacently positioned vertebrae are at least partially separated from each other by a distance greater than their relative position prior to the surgical procedure. Because the distance between adjacent vertebrae is greater than the original position, the elasticity of the surrounding tissue and muscle, at least in part, maintains the inserted prosthesis in a compressed state between the vertebrae It will be. The maximum radius of the generally spherical or ellipsoidal body may instead be such that two adjacently located vertebrae are at least partially at a distance approximately equal to or less than the relative position of both before the surgical procedure. You may choose to leave. Maximum body radius substantially spherical or ellipsoid, usually, to fit entirely perimeter within the intervertebral disc space when the body of substantially spherical or ellipsoid are correctly positioned between two vertebrae Selected.

  Artificial implants are made of materials that are inert and / or biocompatible with the vertebrae and / or surrounding tissue. Artificial implant materials include, but are not limited to, bone, stainless steel, titanium, chromium molybdenum, cobalt chromium alloy, ceramic (zirconium oxide ceramic, aluminum oxide ceramic, etc.), chromium or chromium alloy, cobalt or cobalt alloy , Polycarbonate, polypropylene, polyethylene, polymethyl methacrylate, glass and / or carbon fiber filled polysorbones, and / or various types of carbon and fiber reinforced polymers. As can be appreciated, other and / or alternative materials may be used. One or more materials used may be wear resistant, have a high coefficient of friction, and / or have a low coefficient of friction. The material selected for use in an adult human is typically a disc tissue so as to maintain a tensile load of at least about 2268.0 g (about 5 pounds) against the disc tissue and / or vertebral endplate. And / or designed to maintain a tensile load of about 4536.0 g (about 10 pounds) to about 18143.7 g (about 40 pounds) relative to the vertebral endplate, although the prosthetic implant may have other tensile loads. May be designed to maintain The selected tensile load facilitates maintaining the prosthesis in place between the vertebrae. When using an artificial graft other than a human, the tensile load design of the artificial graft is selected accordingly. At least a portion of the material used to form the prosthesis has an elasticity that approximates that of a vertebra. Artificial grafts facilitate placement of the artificial graft within the body, ease of placement of the artificial graft within the body within a particular portion or region, and / or positioning of the artificial graft during and / or after a surgical procedure May be at least partially coated, fabricated, and / or included with a tracking marker that facilitates. The tracking marker can be a radiographic film (eg, X-ray), MRI image and / or other magnetic wave image, ultrasonography and / or other type of sonography, and / or some other electromagnetic test (eg, Ultrasound, infrared wave, radio wave, ultraviolet wave, etc.) may be included. The artificial implant may include one or more pressure sensors for determining the amount of pressure applied to the artificial implant and / or one or more regions of the artificial implant. The one or more pressure sensors can be placed on and / or within the surface of the artificial implant. The one or more pressure sensors may include one or more visual indicators that display information regarding the applied pressure, and / or the one or more pressure sensors are applied to the prosthesis. It may include a storage device, a transmitter, etc. that can be used to transmit and / or store information regarding the pressure being applied.

  The interior of the spherical body 20 may be solid, hollow, or have one or more cavities. If the spherical body 20 includes one or more cavities, the cavities may be empty or at least partially alter the physical properties (ie, weight distribution, density distribution, etc.) of the spherical body 20. Filled with one or more bioactive substances and / or bioneutral substances that can and / or flow out or escape from the void and enter the bone tissue and / or fluid around the implant Good. The artificial implant 10 further includes a ballast 30 on the spherical body 20. The ballast 30 is illustrated as being disk-shaped and extending around the central axis of the spherical body 20, although it will be appreciated that the ballast may have other shapes, and It may be arranged at other places on the main body 20. The ballast may be made of or include the same or similar material as the material of the spherical body 20, but the ballast may include a different or different material. As can be appreciated, the ballast 30 may be another element that is later connected and / or formed to the outer surface 22.

The ballast 30 facilitates placement of the prosthetic graft, at least in part, between one or more vertebrae and provides a substantially spherical or ellipsoidal body between the one or more vertebrae. It is designed to help limit the amount of motion and / or facilitate the insertion of an artificial implant between one or more vertebrae. The edge 32 of the ballast 30 is usually a rounded and non-sharp edge, but this is not a requirement. By rounding the ballast surface, the nerve exiting the spinal cord is tightened to reduce and / or eliminate pain, injury, and / or paralysis in the patient. The ballast 30 is shown to decrease in thickness as it moves away from the spherical body 20, but the thickness may be designed to be approximately constant, or may increase and decrease after decreasing. You may design so that it may increase later. The ballast 30 has a maximum wall thickness that is smaller than the diameter of the spherical body 20. Generally, the maximum wall thickness of the ballast is less than about 1.5 times the diameter of the spherical body 20, but may be less than about 4 times the diameter of the spherical body 20. However, other wall thicknesses may be used. The ballast 30 is shown as extending from the spherical body 20 radially outward with a substantially constant width, but the width of the ballast may vary. Generally, the maximum radial width of the ballast is less than about twice the diameter of the spherical body 20 and typically less than about one time the diameter of the spherical body 20, although other radial widths can be employed.

  FIG. 2 shows the artificial implant 10 inserted into the human spine 40. The human spinal column 40 includes vertebrae 42, 44, 46 with an intervertebral disc 50 positioned between two adjacently disposed vertebrae. Artificial implant 10 is designed to partially or fully replace a damaged intervertebral disc. As shown in FIG. 2, the vertebrae 42 and 44 are separated by and at least partially supported by the spherical body 20 of the prosthesis 10. The remaining vertebrae are shown to be supported and separated by an intervertebral disc 50 that maintains the space between adjacent vertebrae. The injured portion of the intervertebral disc 50 has been at least partially removed from the area between the prosthetic implant 10 before it is inserted between the vertebrae 42 and 44. The inner surfaces of the vertebrae 42 and 44 are also pretreated before the prosthesis 10 is inserted between them. Such pretreatment typically includes washing away unwanted material from the area between vertebrae, removing bone and / or tissue from the surface of one or more vertebrae, and separating between vertebrae. For example, insertion of tools. After pretreatment of the intervertebral area, the artificial implant 10 is at least partially inserted into the intervertebral space. Depending on the design of the prosthesis, the prosthesis provides for arthrodesis (fusion) and / or arthroplasty (joint formation) between adjacent vertebrae. As the prosthesis 10 is inserted between the vertebrae 42 and 44, the stabilizer 30 limits the movement of the prosthesis 10 between the vertebrae.

  3-8 illustrate some other configurations of the artificial implant. In each configuration, the ballast is not shown to more clearly show the features of the body 20. Accordingly, it should be understood that the various configurations of the body 20 shown in FIGS. 3-8 can be used with one or more ballasts. Specifically, referring to FIG. 3, the spherical body 20 has several openings 60, 64, 70. The opening is depicted in a circular shape, but other shapes may be employed. The dimensions of the openings are selected so that various bioactive substances and / or bioinert substances can be filled therein and / or bone and / or tissue can grow in one or more openings. Is done. When the opening is filled with a bioactive substance and / or a bioinert substance, examples of the filling material include, but are not limited to, drugs, tissues, cells, and the like. Additionally or alternatively, the ballast may be provided with one or more openings to fill it with various bioactive substances and / or bioinert substances, or one bone and / or tissue. Alternatively, it may be possible to grow in a plurality of openings and / or allow fluid to flow therein. The one or more openings may be used to allow the instrument to be connected to the graft to facilitate insertion and / or placement of the graft between the vertebrae. The instrument can be used to insert an artificial graft into the intervertebral disc space with various approaches, such as by anterior, posterior, lateral, and / or lateral vision approaches to the vertebra. The instrument opening is typically threaded to accept a threaded instrument, although other types of connection between the instrument and the body may be used. With the threaded opening, the device can be easily fixed and / or removed from the artificial implant 10. Additionally or alternatively, one or more openings can be used to secure a handle screw to the prosthesis to facilitate attachment of the stabilization system rod or plate to the prosthesis. .

  Next, in FIG. 4, the prosthetic implant 10 includes a spherical body 20 having a plurality of cavities 80, 82, 84. The cavity is substantially cylindrical and penetrates the implant 10, although other shapes may be employed. The cavities are all drawn straight through the center of the spherical body 20, but one or more cavities do not pass through the center of the spherical body 20, and / or one or more A form in which the cavity is not straight is also conceivable. Cavity 80 has openings 60 and 62, cavity 82 has openings 68 and 70, and cavity 84 has openings 64 and 66. The cavities typically contain bioactive and / or bioinert materials and / or allow bone and / or tissue to grow into one or more openings and cavities. However, the cavity may be empty and allow fluid to flow therethrough or remain empty. It should be noted that the ballast also includes one or more cavities in addition or alternatively, filled with various bioactive substances and / or bioinert substances, and one or more openings and Bone and / or tissue may be grown into the cavity and / or fluid may flow therethrough. One or more openings may be used additionally or alternatively to allow the instrument to be connected to the implant, to facilitate insertion and / or positioning of the implant between vertebrae, and / or to be stable It can also be connected to one or more elements of a computerized system. The remaining portion of the spherical body 20 may be solid, hollow, or have one or more cavities. If the spherical body 20 includes one or more cavities, the cavities may be empty, or at least in part, the physical properties of the spherical body 20 (ie, weight distribution, density distribution, etc.). ) And / or bioactive and / or bioinert materials designed to flow out or escape from the cavity and enter the bone, tissue and / or fluid surrounding the artificial implant It may be filled.

  Referring now to FIG. 5, the artificial implant 10 includes a spherical body 20 with no openings. The interior of the spherical body 20 may be solid, hollow, or have one or more cavities. If the spherical body 20 includes one or more cavities, the cavities may be empty, or at least in part, the physical properties of the spherical body 20 (ie, weight distribution, density distribution, etc.). ) And / or filled with bioactive and / or bioinert materials that are designed to flow out or escape from the cavity and enter the bone, tissue, and / or fluid surrounding the prosthesis. It may be. Note that the ballast, or alternatively, the ballast may not have an opening.

  Referring now to FIG. 6, the prosthetic implant 10 includes a spherical body 20 having two openings 60 and 62 between which a cylindrical cavity 80 extends. The cavity is typically filled with bioactive and / or bioinert material, but the cavity may be empty and allow fluid to flow therethrough. One cavity is illustrated as having a volume that is greater than the individual volumes of the cavities 80, 82, 84 of FIG. The remaining portion of the interior of the spherical body 20 may be solid, hollow, or have one or more cavities. If the spherical body 20 includes one or more other cavities, the cavities may be empty, or at least in part, the physical properties (ie, weight distribution, density) of the spherical body 20. Filled with bioactive and / or bioinert materials designed to change the distribution etc.) and / or to flow or escape from the cavity and enter the bone, tissue and / or fluid surrounding the prosthesis May be.

  Referring now to FIG. 7, the prosthetic implant 10 includes a spherical body 20 having an opening 60 that includes a threaded hole 72 designed to receive an insertion instrument, a handle screw and / or a cap 120. The cap 120 includes a threaded portion 122 that is screwed into the opening 60 to at least partially close the opening 60. The cap 120 is designed to partially or completely seal the opening 60. The cap can be designed to be removable or non-removable. The cap allows one or more bioactive and / or bioinert materials to pass through the cap and / or allows one or more bioactive and / or bioinert materials to pass through the cap. Can be designed to prevent or prevent. The cap may be designed such that one or more bioactive and / or bioinert materials can be removed from the opening 60 and / or refilled into the opening 60. Such removal and / or refill can be accomplished by removing the cap, by designing the cap to allow a needle or syringe to penetrate, and / or by providing one or more openings in the cap. Can be realized. The cap may be designed to additionally or alternatively function as a pressure sensor. The cap may itself be a pressure sensor or may include a pressure sensor. Information obtained from the pressure sensor can be used to determine the status of the prosthesis and / or the condition of the prosthesis. As can be appreciated, the pressure information can be used for other and / or additional purposes.

  Next, in FIG. 8, the artificial implant 10 is similar to the artificial implant shown in FIG. 7 and shows that the outer surface 22 is not smooth. Using a non-smooth surface facilitates the partial or total fusion of the surface of the implant with one or more vertebrae. The non-smooth surface can also be designed to engage and / or fix to the lower surface of the vertebra in the intervertebral disc space. It should be noted that a non-smooth surface may be provided on the ballast or alternatively on the ballast.

  9-12, the body of an artificial implant having an outer surface 22 that is at least partially coated with a coating material 90 is shown. As can be appreciated, the outer surface of the ballast, or alternatively, the outer surface of the ballast may be coated with a coating material. The coating material 90 may form a substantially smooth outer surface 92 as shown in FIGS. 9-11, or a non-smooth surface 92 as shown in FIG. The covering material 90 can be made of various materials. Typically, the coating material 90 includes one or more materials that differ from the material composition of the outer surface 22 and / or ballast of the spherical body 20. The covering material 90 has various functions, including but not limited to forming a substantially smooth outer surface over the substantially smooth outer surface as shown in FIG. 9, as shown in FIG. A substantially smooth outer surface and at least partially covering the spherical body 20 and / or an opening in the surface of the ballast to form a substantially smooth surface, as shown in FIG. To cover a non-smooth surface and at least partially cover the spherical body 20 and / or the opening 100 in the ballast surface to form a substantially smooth artificial graft surface, or FIG. As shown, it has the function of forming a non-smooth surface over the spherical body 20 and / or the substantially smooth outer surface 22 of the ballast. As can be appreciated, the coating material may perform other functions.

  As shown in FIG. 10, the coating material is depicted as allowing one or more bioactive materials and / or bioinert materials 110 to pass through the coating material 90 from the opening 100. As can be appreciated, the coating material may be formulated so that one or more bioactive substances and / or bioinert substances do not pass through the coating material and / or one or more substances. May be formulated so that can pass through the coating material and enter one or more openings. The coating material 90 may be formulated to control the flow rate of substances and / or materials entering and exiting the opening 100. Bioactive substances are typically used for a variety of purposes, among other things, to facilitate the formation of a graft between one or more vertebrae, to promote the growth of bone and / or other tissue, It is used for the purpose of suppressing rejection, suppressing infection, reducing inflammation, relieving pain, promoting healing of surrounding tissues, and functioning as a position and / or visual indicator. As can be seen, to facilitate the formation of a graft between one or more vertebrae, to promote bone and / or other tissue growth, to reduce rejection of the artificial graft, to reduce infection, One or more bio-neutral substances (e.g., water) for purposes such as reducing inflammation, relieving pain, promoting healing of surrounding tissue, functioning as a location and / or visual indicator, etc. , Inert or substantially inert compounds, etc.) can also be used.

  Next, as shown in FIGS. 11 and 12, the coating material 90 includes at least one bioactive substance 112 released from the coating material. Such biologically active materials may, but are not limited to, facilitate the formation of a graft between one or more vertebrae, promote bone and / or other tissue growth, and prevent artificial graft rejection. Used to control, control infection, reduce inflammation, relieve pain, promote healing of surrounding tissue, function as a location and / or visual indicator, and so on.

Looking at the various configurations of the prosthesis shown in FIGS. 3-12, the generally spherical or ellipsoidal body of the prosthesis inhibits or prevents bone growth and / or other tissue growth on the outer surface. One or more outer surface regions that promote or promote bone growth and / or other tissue growth on the outer surface. One or more regions of the outer surface may be a substantially smooth outer surface, a non-smooth surface, or a combination thereof. Non-smooth surfaces include, but are not limited to, ridges, ribs, grooves, pits, notches, semi-gloss, slits, slots, channels, corrugations, and the like. By suppressing or preventing bone growth and / or other tissue growth on the outer surface of the prosthesis, the generally spherical or ellipsoidal body can move freely or relatively freely between the two vertebrae It becomes like this. When substantially Oyobi on the body of spherical or ellipsoidal / or bone or other tissue into the body grows, the body of a substantially spherical and / or ellipsoid, would be fixed in position with respect to one or both of the vertebrae Or at least partially retained. This is a problem when such fixation or partial retention is undesirable. The outer surface of the generally spherical or ellipsoidal body may include an abrasion resistant material. The outer surface has low friction to allow good movement between one or more vertebrae and / or to facilitate the insertion and / or placement of an artificial implant between one or more vertebrae It may have characteristics. The one or more outer surface regions that inhibit or prevent bone growth and / or other tissue growth may have a total area that is at least greater than or less than the total outer peripheral area of the generally spherical or ellipsoidal body. Good. One or more outer surface regions of the artificial implant may include a coating material. The coating material forms, at least in part, a substantially smooth outer surface and / or a non-smooth surface on the artificial implant. One or more layers of coating material may be applied to the artificial implant. When two or more coating materials are applied, each coating material layer may be formed of the same material, or may include one or more different materials. A uniform composition of the coating material may be applied to the artificial graft, or one or more portions of the artificial graft may contain a non-uniform composition of the coating material. The one or more coating material layers may be the same or different in one or more regions of the outer surface of the substantially spherical or ellipsoidal body . The coating material may be a biocompatible material. Various polymers and / or copolymers may be included in the coating material to at least partially secure the coating material to the outer surface of the generally spherical or ellipsoidal body . The coating material is at least partially bonded to an approximately spherical or ellipsoidal body by adhesive bonding, welding, brazing, soldering, shrink wrapping, melting, spray coating, hop dipping, electroplating, dip coating, brush coating For example, it may be fixed. At least a portion of the coating material may be biologically neutral. At least a portion of the coating material may include one or more biological materials that are bio-neutral and / or bioactive. Various materials (bio-neutral and / or biological activity) that can be included in the coating layer include, but are not limited to, natural and / or synthetic bone cement, urethane foam, epoxy compound, pain relief, bone growth promotion, Formulations for bone growth inhibition, tissue growth promotion, tissue growth inhibition, rejection inhibition, inflammation inhibition, infection inhibition and / or prevention (eg, self-grown compounds, bone, polyglycolate polymer or similar, lactide , Polydioxamon, polyglycolate, lactide / glycolide copolymer, antithrombotic agent, steroid, ceramine and / or derivative thereof, thioprosthesis inhibitor, nitric oxide, ibuprofen, aspirin, antibacterial agent, antibiotic, tissue protoplast active agent, Monoclonal antibody, antifibrotic compound, growth factor interferon, steroid, pe Syrin, cephalosporin, aminoglycoside, antidepressant anti-mitotic agent, sense / antisense oligonucleotide (eg, DNA, RNA, plasmid DNA, plasmid RNA, nucleic acid analog (eg, peptide nucleic acid)), inhibitor, Radioactive substances, toxins, growth factors, oligonucleotides, antiplatelet compounds, antitaborite compounds, anti-inflammatory compounds, anticoagulant compounds, antimitotic compounds, antioxidants, antibacterial agents, antibiotics, antimetabolites, antimigration Agent, anti-matrix compound, protein kinase inhibitor, anti-vital compound, antifungal compound, antiprotozoal compound, tissue protoplast active agent, monoclonal antibody, antifibrosis compound, hormone agent, antiproliferative agent, antiplatelet compound, metabolic inhibition Agent, anti-neoplastic agent, growth inhibitor, cytotoxic compound, anticoagulant, fibrinolytic agent Thrombin inhibitor, anti-mitotic agent, antitumor compound, cholesterol-lowering agent, vasodilator, antisense oligonucleotide, human tissue, animal tissue, synthetic tissue, human cell, animal cell, synthetic cell, hydroxyapatite bone and / Or protein, cartilage activating factor, bone stimulating substance, bone growth substance, bone activating substance, tissue stimulating substance, tissue growth substance, tissue activating substance, bone growth inhibitor, bone growth promoter, tissue growth promoter, Tissue growth inhibitors, rejection inhibitors, etc.). As can be appreciated, the bio-neutral and / or bio-active substance may include other compounds. The coating material can include one or more bioactive substances that can migrate from the coating material and / or dissociate from the coating material and enter the surrounding tissue. One or more bioactive substances contained in the coating material are released instantaneously or nearly instantaneously and enter the surrounding tissue when and / or after the artificial implant is inserted between the vertebrae. Or can be released with a slight delay after the prosthesis is inserted between the vertebrae. If released slightly later, it may be released uniformly or variously. The release rate varies depending on the type of bioactive substance released and / or the release location on the artificial implant. Delayed release of one or more bioactive substances can be accomplished by one or more mechanisms, including, but not limited to, 1) one or more dissolved materials in the coating material At least partially encapsulating or encapsulating the bioactive agent, 2) covalently and / or ionicly attaching one or more bioactive agents to one or more other coating materials . The coating material may include one or more substances that increase the strength and / or durability of the artificial graft and / or harden or soften the surface of the artificial graft. The generally spherical or ellipsoidal body of the artificial graft promotes or inhibits bone growth and / or growth of other tissues on and / or in the surface of the generally spherical or ellipsoidal body of the artificial graft. May include one or more depressions and / or openings. One or more depressions and / or openings may be at least partially coated with a coating material. The generally spherical or ellipsoidal body may include one or more internal cavities. These cavities include one or more passages to the outside surface of the body of the generally spherical or ellipsoidal, also be terminated at the opening of the outer surface of the body of a substantially spherical or ellipsoidal or substantially spherical Or it may be substantially separated from the outer surface of the ellipsoidal body . The at least one cavity may be substantially empty or may include one or more bioactive and / or bioneutral materials. The one or more cavities of the generally spherical or ellipsoidal body are adapted to allow blood and / or other bodily fluids to flow into and / or out of the one or more cavities. The dimension of the passage and / or opening on the outer surface of the substantially spherical or ellipsoidal body is the amount and / or speed of the one or more bioactive substances in and out of the one or more cavities Can be selected to control. The dimensions of the passage and / or opening relative to the outer surface of the generally spherical or ellipsoidal body may result in bone and / or other tissue occurring within the opening and / or passage and / or into one or more cavities. Can be selected to control the amount and / or rate of growth. The one or more bioactive and / or bioneutral substances in the one or more cavities are before, during, and / or after the insertion of the prosthesis between the one or more vertebrae. Can be at least partially filled. One or more of the volume of each cavity of the body of substantially spherical or ellipsoid is smaller than the total volume of the body of the generally spherical or ellipsoidal. If the generally spherical or ellipsoidal body includes two or more cavities, the cavities may have the same or different volumes. At least two cavities within the generally spherical or ellipsoidal body may be in fluid communication with each other. Each of the one or more cavities may vary in shape and / or size. The generally spherical or ellipsoidal body of the artificial graft provides one or more openings on its outer surface to facilitate positioning of the artificial graft between the vertebrae and within the disc space Secure the artificial implant in place and / or connect one or more elements of a spinal stabilization system (eg, cage, plate, screw, rod, nail, post, etc.) to the artificial implant. be able to. One or more openings in the outer surface of the generally spherical or ellipsoidal body are artificially implanted between the vertebrae of the spine by anterior, posterior, lateral and / or lateral entry into the spinal column It can be designed to accept instruments for guiding and / or inserting pieces. The at least one opening may include a locking mechanism, such as, but not limited to, a screw within the opening to secure the instrument within the opening. One or more openings in the outer surface of the generally spherical or ellipsoidal body of the prosthetic implant may be used before, during, and / or during insertion of the prosthetic implant between one or more vertebrae. Later, it can be at least partially closed and / or sealed. A cap can also be used to close and / or seal at least partially one or more openings of the generally spherical or ellipsoidal body . The cap at least partially controls the amount and / or rate of the bioactive material exiting the one or more openings and / or the material entering the openings (eg, bone, tissue, etc.) The size of the one or more openings may be varied to at least partially control the speed and / or amount of. The cap may be made of a porous material or a non-porous material. The cap is a sealable or non-sealable opening used to provide a passage through the cap for inserting one or more bioactive and / or bioneutral materials through the cap into the body portion of the prosthesis. May be included. The cap opening includes a sealable material through which the syringe can be inserted to insert one or more bioactive and / or bioneutral materials into the artificial implant and remove the syringe. And the hole may be sealed again. The cap receives an instrument for guiding and / or inserting the cap into one or more openings of the generally spherical or ellipsoidal body and / or is connected to one or more elements of the ballast system. So that it can be designed. The cap can be made of a biocompatible material. The cap may be made of or include a material that is the same as or different from the material forming the generally spherical or ellipsoidal body . At least one surface of the artificial implant is rounded and / or smooth and not pointed. The rounded surface reduces and / or eliminates the pinching of nerves leading from the spinal cord that can cause pain, injury, and / or paralysis in the patient. By rounding and / or smoothing the surface, the nerve pressure acting on the nerves emerging from the spinal cord between the vertebrae can be avoided or minimized. The one or more rounded and / or smooth surfaces can also facilitate the insertion of the prosthetic implant within the intervertebral disc space.

The prosthetic implant may include at least one ballast that at least partially surrounds the generally spherical or ellipsoidal body thereof. This ballast facilitates at least partially placing an artificial implant between one or more vertebrae and limits the amount of movement between one or more vertebrae of a generally spherical or ellipsoidal body. And / or designed to facilitate the insertion of an artificial implant between one or more vertebrae. At least one ballast, be arranged around the substantially central axis of the body of substantially spherical or ellipsoidal may be positioned substantially offset from the center axis of the main body of substantially spherical or ellipsoid. The ballast may have a substantially disk shape, but the shape of the ballast is not necessarily limited to such a shape. The ballast may extend a substantially uniform distance or a non-uniform distance from the outer surface of the generally spherical or ellipsoidal body of the artificial implant. One or more portions of the ballast may extend from the outer surface of the generally spherical or ellipsoidal body of the artificial implant by a distance of up to about 300% of the maximum diameter of the generally spherical or ellipsoidal body . Typically, the ballast extends at least about 0.0005 mm from the outer surface of the generally spherical or ellipsoidal prosthesis, although other distances may be used. Maximum thickness of the ballast is smaller than the maximum diameter of the body of the generally spherical or ellipsoidal artificial grafts (e.g., from 0.001 to 99% of the maximum diameter of the body of the generally spherical or ellipsoidal). The ballast wall thickness may be substantially constant or may vary along the radial width of the ballast. The method of decreasing the thickness may be constant or variable. The ballast may have one or more tapered edges. The ballast is at least partially porous, non-porous, non-biodegradable, and / or biodegradable (eg, bone, synthetic bone, stainless steel, titanium, chrome molybdenum, cobalt chrome Alloys, ceramics (zirconium ceramics, aluminum oxide ceramics, etc.), chromium or chromium alloys, cobalt or cobalt alloys, polycarbonate, polypropylene, polyethylene, polymethyl methacrylate, glass and / or carbon fiber filled polysulfones, and / or various carbons and Fiber reinforced polymer). The ballast may be coated with and / or contain one or more bioactive and / or bioneutral materials. Such biologically active and / or bioneutral materials can, but are not limited to, facilitate the formation of a graft between one or more vertebrae, promote bone and / or other tissue growth, It can be used to suppress graft rejection, suppress infection, suppress inflammation, relieve pain, promote healing of surrounding tissue, function as a location and / or visual indicator, and the like. The ballast may include an abrasion resistant material. The ballast may include materials that increase or decrease the coefficient of friction. A ballast and / or a coating that at least partially coats the ballast makes at least a portion of the ballast's outer surface smooth, rough, low-friction, wear-resistant, etc. be able to. The type of material used to form the ballast and / or the type of coating material applied to one or more portions of the ballast is included in the generally spherical or ellipsoidal body of the artificial implant. And / or the coating material used for the generally spherical or ellipsoidal body of the artificial implant may be the same, similar or different. The manner of applying one or more layers of coating material to the ballast may be the same as or different from the manner of applying one or more layers of coating material to the generally spherical or ellipsoidal body of the prosthesis. The ballast may include one or more openings and / or cavities. The openings and / or cavities may contain various bioactive and / or bioneutral substances. Such biologically active and / or bioneutral materials can, but are not limited to, facilitate the formation of a graft between one or more vertebrae, promote bone and / or other tissue growth, It is used for the purpose of suppressing graft rejection, suppressing infection, suppressing inflammation, alleviating pain, promoting healing of surrounding tissues, and functioning as a position and / or visual indicator. The ballast may include one or more layers of coating material that include one or more bioactive agents that move from the coating material and / or break down from the coating material and enter the surrounding tissue. . One or more bioactive substances inserted, encapsulated and / or at least partially bonded to the coating material, release to the surrounding tissue, at least partially controlled release time Release can be and / or immediate release. The coating material can increase the strength and / or durability of the ballast and / or harden or soften the ballast surface. The ballast may be removable from the generally spherical or ellipsoidal body of the artificial implant, or may be connected substantially permanently. The ballast and the generally spherical or ellipsoidal body may be composed of single or multiple components. The angle of articulation to the outer surface of the generally spherical or ellipsoidal body of the ballast may be constant or vary from an angle less than about 0.01 ° to an angle of about 180 °. The ballast may expand at least partially before, during, and / or after insertion of the prosthetic graft at least partially between the two vertebrae. The amount of expansion may be a predetermined or set amount or a non-preset or variable amount.

The substantially spherical or ellipsoidal body of the artificial implant is formed of a single part or a plurality of parts. Each part may be the same or different in shape, dimensions, material composition, physical properties, number of cavities, surface morphology, openings, internal components, and the like. The inflatable material used to at least partially form the ballast is disposed between two or more parts of the generally spherical or ellipsoidal body of the artificial implant. The inflatable material may include an elastic bag or sac designed to at least partially receive the material, and may be at least partially inflated, and / or The expandable material is at least partially in one or more mechanisms (eg, exposure to heat, exposure to pressure, chemical reaction, exposure to electric current, exposure to electromagnetic waves, exposure to magnetic waves, etc.) It may be a malleable or moldable material that can be expanded. The inflatable material can include one or more mechanisms (eg, adhesives and / or other types of chemical bonds, melt bonds, mechanical connections (ie, tacks, nails, screws, wires, cords, clamps, clips, hooks) , Dowels, rivets, bolts, pins, seams, hook and loop fasteners, etc.), magnetic connections, inflatable materials, one or more channels of one or more parts of a generally spherical or ellipsoid body , Can be permanently or removably connected to one or more parts of the generally spherical or ellipsoidal body of the artificial implant. Two or more parts of a generally spherical or ellipsoidal body may include one or more mechanisms (eg, adhesive and / or other types of chemical bonds, melt bonds, mechanical connections (ie, tacks, nails) , Screws, wires, cords, clamps, clips, hooks, dowels, rivets, bolts, pins, seams, hook-and-loop fasteners, etc.), magnetic connections, etc.) or permanently. The connection of two or more generally spherical or ellipsoidal parts allows, prevents, or limits relative movement between the two or more parts. When forming a ballast, the inflatable material can be placed in close proximity to or away from the central axis of the generally spherical or ellipsoidal body of the artificial implant. When forming two or more ballasts, two or more inflatable material portions can be placed in different regions of a generally spherical or ellipsoidal body . The radial axes of the plurality of ballasts in the expanded state may or may not be parallel. A portion of the generally spherical or ellipsoidal body of the prosthesis can be inflatable and / or deflated. Expansion or contraction of one or more portions of the generally spherical or ellipsoid body can increase or decrease the size and surface area of the prosthesis. Utilizing the expansion and / or contraction of one or more portions of a generally spherical or ellipsoid body can facilitate the insertion and / or positioning of an artificial implant between two vertebrae. If the generally spherical or ellipsoid body is formed of two or more parts, one or more parts can be designed to expand and / or contract. Expansion and / or contraction of at least one or more portions of the generally spherical or ellipsoidal body can occur at the same time or at a different time than the expansion of the ballast. The amount of increase and / or decrease in expansion / contraction of the generally spherical or ellipsoidal body may be substantially uniform or may vary. The mechanism for inflating and / or deflating one or more portions of the generally spherical or ellipsoidal body is typically similar to the one or more mechanisms used to inflate the ballast, but others This mechanism can also be used. The expandable and / or retractable portion of the generally spherical or ellipsoidal body may include one or more materials used for the inflatable ballast. As can be appreciated, at least partial expansion and / or contraction of one or more portions of the generally spherical or ellipsoidal body may occur prior to, during, and / or during the insertion of the prosthesis between the vertebrae. Can be done after insertion.

  The prosthetic graft may be at least partially inserted between the vertebrae, during and / or after insertion, and / or during and / or after expansion of the stabilizer and / or body. One or more pressure sensors may be included that are used to monitor the pressure applied to one or more portions or regions of the prosthetic implant. Monitoring the pressure applied to one or more areas of the prosthesis facilitates a) determining that the correct size of the prosthesis has been selected, and b) allowing the prosthesis to perform a specific procedure. Make it easier to verify that it is made of the correct material, and c) monitor the expansion of the ballast to ensure that the ballast is in an overexpanded or underexpanded state, and if so is stable D) monitor the expansion of the body of the prosthesis to make sure that the body is in an over-expanded or under-expanded state, and if so, reduce the ballast if necessary E) make it easier to inflate, and e) monitor the stress and / or pressure on the prosthetic graft to see if the prosthetic is dysfunctional, working properly, or misaligned F) Artificial transfer Monitoring the wear pieces, g) monitoring the healing and / or damage of surrounding tissue, and / or to monitor the operation of the artificial grafts have been utilized. Information obtained from one or more pressure sensors is obtained or downloaded periodically or obtained or downloaded continuously. Information obtained or downloaded from one or more pressure sensors is analyzed manually and / or electronically (eg, a computer program, etc.). As can be appreciated, other and / or additional uses of pressure information are contemplated by the present invention. The one or more pressure sensors are at one or more surface locations of the body and / or ballast and / or at least partially at one or more locations on the body portion and / or ballast. Placed or embedded. The one or more pressure sensors may include visual and / or audio indicators to provide information regarding the pressure being detected. The one or more pressure sensors may additionally or alternatively transmit (via wiring, cable, optical fiber, wireless, etc.) and / or store information regarding the pressure being detected. Wireless transmission may be by one or more types of electromagnetic waves, magnetic waves, and / or sound waves.

  FIGS. 13-16 illustrate several examples of various mechanisms that at least partially expand the ballast to the desired shape and / or dimensions. As shown in FIGS. 13-16, the ballast can be inflated at least in part by one or more mechanisms. Such mechanisms include, but are not limited to, expansion by inserting fluid into the artificial implant, expansion of one or more elements of the artificial implant using one or more shape memory metals, Expansion by chemical reaction of one or more elements of the artificial graft, expansion by applying a compressive force to one or more materials of the artificial graft, and the like. One or more of these mechanisms can be implemented in various ways. For example, at least partial expansion by insertion of fluid 1) fluid (eg, liquid, gas, etc.) into one or more regions of the prosthesis until the desired amount of expansion of the ballast is achieved. And / or 2) one or more internal channels and / or cavities of the prosthesis until the design expansion of the ballast is achieved, with a pressure device (eg, syringe, pump, etc.) and / or Over and / or in an artificial implant to allow fluid (eg, liquid, gas, malleable and / or moldable compounds (ie, curable polymers, polymer pastes, etc.)) to flow into This is realized by feeding a fluid from the inside with a fluid pressure device (for example, a pump or the like) disposed in the. As can be appreciated, other mechanisms may additionally or alternatively be used to inflate upon fluid insertion. At least partial expansion due to the use of one or more shape memory metals may result in one or more shape memory materials (e.g., one or more regions of the prosthesis, whether or not the composition is the same) , Metals, polymers, etc.) and using heat, current, electromagnetic waves, sound waves, etc., this shape memory material is at least partially returned to the memory configuration and the ballast is expanded until the desired expansion is achieved. Can be realized. As can be appreciated, other inflation mechanisms through the use of one or more shape memory materials may alternatively or alternatively be used. At least partial expansion by using a chemical reaction of one or more elements inserts one or more reactants and / or catalysts into one or more regions of the artificial implant (eg, a syringe, Can be achieved by causing a chemical reaction and, consequently, expanding the ballast. This reaction may occur as a result of simply introducing one or more reactants and / or catalysts into the artificial implant and / or by introducing heat, current, magnetic waves, electromagnetic waves, sound waves, etc. It can also be generated and / or accelerated. Expansion due to chemical reaction may be due to the formation of one or more volume increasing compounds (eg, urethane foam, etc.) and / or as a result of the reorganization of one or more compounds increasing in volume. Good. Expansion utilizing a chemical reaction of one or more elements may include one or more reactants and / or catalysts in addition to or instead of one or more channels or cavities of an artificial implant. It can also be achieved by means of a chemical reaction that is inserted internally into the tube (for example by means of a pump placed on and / or in the artificial implant) and consequently inflates the ballast. As can be appreciated, other mechanisms of expansion utilizing chemical reactions can be used additionally or alternatively. At least partial expansion by applying a compressive force to one or more materials of the prosthetic graft is: 1) while the prosthetic graft is at least partially inserted between vertebrae and / or after insertion The compressive force exerted by the vertebra on the graft causes the malleable, moldable, and / or fluidic material to face outward from the body of the prosthesis until the ballast design expansion is achieved. 2) by mechanically compressing one or more parts of the artificial implant with screws, clamps, rod inserts, magnets, etc., to be malleable, moldable and / or fluidic This can be achieved by allowing the material to flow outwardly from the body of the prosthesis until the ballast design expansion is achieved. As can be appreciated, other expansion mechanisms that utilize compressive forces may additionally or alternatively be utilized. In one or more non-limiting expansion mechanisms described above, the expanded ballast and / or one or more elements of the expanded ballast can be combined with one or more mechanisms (eg, natural drying, chemical reaction, etc. (Introduction of heat, current, sound waves, electromagnetic waves, one or more catalysts and / or reactants, magnetic waves, etc.)) and / or at least partially cured. Inflatable material includes, but is not limited to, an elastic or flexible bag or sac that is designed to at least partially receive a material that at least partially inflate the sack or sac. And / or the expandable material can have one or more mechanisms (eg, exposure to heat, exposure to pressure, chemical reaction, exposure to electric current, exposure to electromagnetic waves, exposure to magnetic waves, Malleable or moldable materials (eg cement materials, epoxy materials, thermoplastic materials, elastomers, thermosetting materials, photocuring) that can be at least partially expanded by shape memory metals or polymers, etc. Resin or thermosetting resin).

  Specifically, FIG. 13 shows an artificial implant 120 that includes a spherical body 130 formed of two hemispherical portions 132, 134 having outer surfaces 136, 138, respectively. The artificial implant 130 also includes an inflatable ballast 140 connected to the spherical body 130. The ballast and the two hemispherical parts form three separate elements of the prosthesis as shown in FIG. Usually, the two hemispherical parts are made of a durable material that resists deformation when subjected to compressive forces. The material or materials forming the ballast may also be made of a durable material. The material that forms the ballast is generally different from the two hemispherical parts, and the material that forms the two hemispherical parts generally does not change shape, whereas the material that forms the ballast Some materials are inflatable, flowable, and malleable. The ballast includes an elastic bag or pouch that contains and / or receives one or more materials. Additionally or alternatively, the ballast is connected to the two hemispherical parts and forms a cavity between the two hemispherical parts to enclose and / or receive one or more materials therein An elastic wall may be included so that The material or materials that are contained or will be received inflates the bag or sac or wall under certain conditions (eg, internal pressure due to chemical reaction, deformation, growth, etc.) and at least partly Is selected to form an inflated ballast. The ballast may include a viscous material that will be, but not necessarily, encased in an elastic material. Viscous materials are typically malleable and / or expandable materials that deform and / or expand under certain conditions to at least partially form an expanded ballast. . The ballast 140 is shown in an unexpanded state. The outer periphery of the ballast 140 is shown to be substantially flush with the outer surfaces of the two hemispherical portions. It should be noted that at least a part of the outer periphery of the ballast may be recessed from the outer surfaces of the two hemispherical portions and / or extend outward from the outer surfaces of the two hemispherical portions. A syringe 142 is used to inject substance 148 through needle 144 into one of the two hemispherical portions by pushing plunger 146 as shown by the arrow. As can be appreciated, the syringe can inject material into the other hemispherical portion, both hemispherical portions, and / or the ballast. As can be appreciated, other devices can be used to inject the material. The substance can be injected into the artificial implant through the outer wall of the body and / or ballast or through the opening of the body or ballast. As can be appreciated, a cap designed to accept a syringe needle can be inserted over the opening. With this structure, the substance can be put into the opening through the cap, and the substance can be prevented or prevented from flowing out of the opening after the needle is removed from the cap. Substances inserted into the body of the artificial implant include bio-neutral substances (eg, water, saline, inert fluids, etc.), bio-active substances, and / or chemically reactive substances and / or catalysts. . The viscosity of the injected material ranges from a wide range (eg, approximately from the viscosity of water (0.001 Pas (1 cps, @ 70 ° C.)) to the viscosity of high viscosity gel, putty, or coke (150-100000 Pas (150,000- 100,000,000 + cps, @ 70 ° C))). Bioactive and / or bio-neutral material insertion can be used to expand the ballast due to internal pressure applied to the ballast by material insertion. The material is injected until the ballast expands to the desired size and / or shape indicated by 140A. The reaction is carried out using the insertion of chemical reactants and / or catalysts, a) at least partially curing and / or solidifying the expanded ballast, and / or b) at least partially expanding the ballast. be able to. The inserted chemical reactant and / or catalyst may be designed to react with one or more substances already in the ballast, or all the reactants may be inserted into the ballast. The reaction may occur immediately or subsequently. As can be appreciated, the chemical reaction can be induced at least in part by current, electromagnetic waves, acoustic waves, heat, magnetic waves, and the like. The amount of chemical reactant and / or catalyst that is inserted can be used to control the amount of expansion of the ballast. A chemical reaction can be selected to produce an expanding product, and the ballast can be expanded by internal pressure from the expanding product. After ballast 140A has expanded to the desired shape and / or dimensions, if necessary, by naturally curing the material in the ballast and / or heat, current, electromagnetic waves, acoustic waves, magnetic waves, and The expanded ballast may be cured by inducing curing using a chemical reaction. Although the inflated ballast 140A is illustrated as being disc-shaped and extending about the central axis of the spherical body 130, the ballast may have other shapes and / or the body. You may arrange | position in the other position of a part.

  Referring now to FIG. 14, an artificial implant 150 is shown that includes a spherical body 160 formed of two hemispherical portions 162, 164 having outer surfaces 166, 168, respectively. The artificial implant 150 also includes an inflatable ballast 170 connected to the spherical body 160. The ballast and the two hemispherical parts form three separate elements of the prosthesis shown in FIG. Typically, the two hemispherical parts are made of a durable material that resists deformation when subjected to compressive forces. The material or materials forming the ballast are also made of a durable material that is designed to deform when subjected to an external compressive force and / or an internal expansion force. Yes. Depending on the deformation characteristics of the material or materials forming the ballast, the ballast can be expanded under certain circumstances. The ballast 170 is shown in an unexpanded state. The outer periphery of the ballast 170 is shown substantially flush with the outer surfaces of the two hemispherical portions. It should be noted that at least a portion of the outer periphery of the ballast may be recessed from the outer surfaces of the two hemispherical portions and / or extend outwardly from the outer surfaces of the two hemispherical portions. The hemispherical portion 162 is illustrated as including a screw screw 171 having a slot 174 in the screw head 172. The slot is designed to accept an instrument for turning the screw. The screw 171 has one or more screws 178 in the screw body 176. The body of the screw is designed to screw into a threaded hole 184 in the body 182 of the cylinder 180 located within the hemispherical portion 164. As can be appreciated, the top of the cylinder may be provided with a slot for rotation or may be fixed in place. When the screw 171 is turned in the direction of the arrow, the screw body is screwed into the cylindrical body 180 and the two hemispherical parts move relative to each other to compress the ballast 170. When the ballast is compressed, the ballast expands to the expanded state shown at 170A. The material or materials forming the ballast may have a viscosity (eg, from about the viscosity of water (0.001 Pas (1 cps, @ 70 ° C.)) to a highly viscous putty or coke (150- 100,000 Pas (from 150,000 to 100,000,000 cps, @ 70 ° C.) includes a wide range of materials, as needed after ballast 170A has expanded to the desired shape and / or dimensions. Expanded ballast by naturally curing the material in the ballast and / or inducing curing using heat, current, electromagnetic waves, sound waves, magnetic waves, and / or chemical reactions Although the inflated ballast 170A is disk-shaped and is illustrated as extending around the central axis of the spherical body 160, the ballast may be of other shapes. Good and / or You may arrange | position in the other position of a main body.

  Referring now to FIG. 15, an artificial implant 190 is shown that includes a spherical body 200 formed of two hemispherical portions 202, 204 having outer surfaces 206, 208, respectively. The prosthetic implant 190 also includes an inflatable ballast 210 connected to the spherical body 200. The ballast and the two hemispherical parts form three separate elements of the prosthesis shown in FIG. Typically, the two hemispherical parts are made of a durable material that resists deformation when subjected to compressive forces. The material or materials forming the ballast are also made of a durable material that is designed to deform when subjected to an external compressive force and / or an internal expansion force. Yes. Depending on the deformation characteristics of the material or materials forming the ballast, the ballast can be expanded under certain circumstances. Ballast 210 is shown in an unexpanded state. The outer periphery of the ballast 210 is shown substantially flush with the outer surfaces of the two hemispherical portions. It should be noted that at least a portion of the outer periphery of the ballast may be recessed from the outer surfaces of the two hemispherical portions and / or extend outwardly from the outer surfaces of the two hemispherical portions. A shape memory material 220 is disposed in the ballast and / or in one or both of the hemispherical portions. The shape memory material is typically a shape memory metal and / or polymer. The shape of the shape memory material may vary widely. Shape memory materials are designed to at least partially return to a memory configuration when exposed to some stimulus (eg, heat, current, sound waves, magnetic waves, electromagnetic waves, etc.). As a result of the shape memory material returning to some form of memory, the shape memory material acts directly on the ballast (eg, by contact) and / or indirectly to the ballast (eg, separate movement of the shape memory material). Acting on the material, which in turn acts on the ballast, etc.), causing the ballast to expand to the expanded state indicated by reference 210A. The material or materials forming the ballast may have a viscosity (e.g., from about the viscosity of water (0.001 Pas (1 cps, @ 70 ° C) to high viscosity putty, or coke (150-100, 000 Pas (up to a viscosity of 150,000 to 100,000,000 cps, @ 70 ° C.) includes a wide range of materials, as needed after ballast 170A has expanded to the desired shape and / or dimensions. Expanded ballast by naturally curing the material in the ballast and / or inducing curing using heat, current, electromagnetic waves, sound waves, magnetic waves, and / or chemical reactions The inflated ballast 210A is disk-shaped and extends around the central axis of the spherical body 160, but the ballast may have other shapes. And / or body You may arrange | position in the other position of a part.

  Referring now to FIG. 16, an artificial implant 230 is shown that includes a spherical body 240 formed of two hemispherical portions 242, 244 having outer surfaces 246, 248, respectively. The artificial implant 230 also includes an inflatable ballast 250 connected to the spherical body 230. The ballast and the two hemispherical parts form three separate elements of the prosthesis shown in FIG. Typically, the two hemispherical parts are made of a durable material that resists deformation when subjected to compressive forces. The material or materials forming the ballast are also made of a durable material that is designed to deform when subjected to an external compressive force and / or an internal expansion force. Yes. Depending on the deformation characteristics of the material or materials forming the ballast, the ballast can be expanded under certain circumstances. The ballast 250 is shown in an unexpanded state. The outer periphery of the ballast 250 is shown substantially flush with the outer surfaces of the two hemispherical portions. It should be noted that at least a portion of the outer periphery of the ballast may be recessed from the outer surfaces of the two hemispherical portions and / or extend outwardly from the outer surfaces of the two hemispherical portions. Two electrodes 260 and 262 are connected to the ballast. The electrodes are designed to pass current through the ballast. The ballast is made of a material that expands when an electric current is passed. The material or materials forming the ballast may have a viscosity (e.g., from about the viscosity of water (0.001 Pas (1 cps, @ 70 ° C) to high viscosity putty, or coke (150-100, 000 Pas (up to a viscosity of 150,000 to 100,000,000 cps, @ 70 ° C.) includes a wide range of materials, as needed after ballast 250A has expanded to the desired shape and / or dimensions. Expanded ballast by naturally curing the material in the ballast and / or inducing curing using heat, current, electromagnetic waves, sound waves, magnetic waves, and / or chemical reactions Although the inflated ballast 250A is illustrated as being disk-shaped and extending about the central axis of the spherical body 240, the ballast may be of other shapes. Good and / or Or you may arrange | position in the other position of a main-body part.

  Next, FIG. 17 shows an artificial implant I that includes a spherical body B and an inflated ballast S connected to the spherical body B. FIG. The ballast is depicted such that the radial width changes and the outer wall thickness of the ballast also changes. The final shape of the ballast can be selected to meet various needs and circumstances.

  Next, FIGS. 19A and 19B show two enlarged cross-sectional views of the ends of the two ballasts S. FIG. FIG. 19A shows a ballast S having a substantially constant wall thickness. FIG. 19B shows a ballast S with a tapered wall thickness. Next, FIGS. 20A and 20B show two enlarged cross-sectional views of the ends of the two ballasts S. FIG. FIG. 20A shows the ballast S expanding substantially perpendicular to the outer surface of the body of the artificial implant. FIG. 20B shows the ballast S expanding at an angle that is not perpendicular to the outer surface of the body of the prosthesis. As can be appreciated, the size, shape, and / or configuration of the inflated ballast can be set according to the specific situation.

  The present invention has been described above with reference to a preferred embodiment. Obviously, various modifications to the preferred embodiment, as well as other embodiments, can be envisaged from the disclosure herein, and thus the above description is only intended to illustrate the present invention, This should not be construed as limiting. All such modifications and changes are intended to be included within the scope of the claims.

It is an expansion perspective view of the artificial graft of this invention. FIG. 6 is an enlarged side view showing a portion of a spinal column containing an artificial implant of the present invention placed between two adjacently placed vertebrae. It is an expansion perspective view of the artificial graft to which the change of this invention was added. It is an expansion perspective view of another artificial graft which added the change of this invention. It is an expansion perspective view of another artificial graft which added the change of this invention. It is an expansion perspective view of another artificial graft which added the change of this invention. It is an expansion perspective view of another artificial graft which added the change of this invention. It is an expansion perspective view of another artificial graft which added the further change of this invention. It is an expanded sectional view of the surface of the artificial graft showing a state in which a coating material is applied to the smooth outer surface of the main body of the artificial graft. It is an expanded sectional view of the surface of the artificial graft showing a state in which a coating material is applied to the outer surface of the main body of the artificial graft having a plurality of openings. It is an expanded sectional view of the surface of the artificial graft showing a state in which the coating material is applied to the non-smooth outer surface of the main body of the artificial graft having a plurality of openings. It is an expanded sectional view of the surface of the artificial graft showing a state in which a coating material whose surface is not smooth is applied to the outer surface of the main body of the artificial graft. 1 is an enlarged perspective view of an artificial implant of the present invention showing the expansion of the ballast by some type of mechanism. FIG. FIG. 5 is an enlarged perspective view of an artificial implant of the present invention showing the expansion of the ballast by another type of mechanism. FIG. 6 is an enlarged perspective view of the prosthetic implant of the present invention showing the expansion of the ballast by yet another type of mechanism. FIG. 6 is an enlarged perspective view of the prosthetic implant of the present invention showing the expansion of the ballast by yet another type of mechanism. 1 is an enlarged perspective view of an artificial implant of the present invention showing a ballast having a variable radius width. FIG. 1 is an enlarged perspective view of an artificial implant of the present invention showing an artificial implant formed from three elements. FIG. It is an expanded sectional view of the edge part of a ballast. It is an expanded sectional view of the edge part of a ballast. FIG. 6 is an enlarged cross-sectional view of the end of the ballast drawn relative to the central axis of the artificial implant. FIG. 6 is an enlarged cross-sectional view of the end of the ballast drawn relative to the central axis of the artificial implant.

Claims (45)

An artificial implant for at least partially supporting the adjacent vertebrae of the spinal column, the artificial graft,
A body that is substantially spherical or ellipsoid;
At least one inflatable element , in part expandable radially outward from the outer surface of the body, and at least one of the at least one inflatable element At least one inflatable element , part of which forms a ballast;
With
The at least one expandable element includes: exposure to heat, chemical reaction, exposure to electric current, exposure to electromagnetic waves, exposure to magnetic waves, and exposure to pressure by a fluid contained within the element. An artificial implant made from a malleable or moldable material that can be expanded by one or more of the following mechanisms . The artificial graft according to claim 1,
An artificial implant wherein at least a portion of the generally spherical or ellipsoidal body includes the at least one inflatable element. The artificial implant according to claim 1,
The prosthetic implant, wherein the at least one inflatable element is disposed, at least in part, on or around an outer surface of the generally spherical or ellipsoidal body. The artificial implant according to claim 1,
The artificial implant wherein the at least one inflatable element is at least partially inflatable about a central axis of the generally spherical or ellipsoidal body. The artificial implant according to claim 1,
The at least one inflatable element comprises at least one bioactive agent;
The artificial implant wherein the at least one bioactive agent covers the at least one inflatable element, or is within the at least one inflatable element, or a combination thereof. The artificial implant according to claim 1,
The at least one inflatable element includes at least one bioactive substance to at least partially inhibit tissue growth, bone growth, or a combination thereof on at least a portion of the at least one inflatable element. An artificial implant comprising at least one bio-neutral substance, or a combination thereof. The artificial implant according to claim 1,
The at least one inflatable element includes at least one bioactive agent to at least partially promote tissue growth, bone growth, or a combination thereof on at least a portion of the at least one inflatable element. An artificial implant comprising at least one bio-neutral substance, or a combination thereof. The artificial implant according to claim 1,
An artificial implant wherein at least a portion of the at least one inflatable element includes a substantially smooth surface. The artificial implant according to claim 1,
At least a portion of the at least one inflatable element includes a substantially non-smooth surface. The artificial implant according to claim 1,
The at least one inflatable element has a maximum radial expansion width in the range of up to 300% of the maximum diameter of the generally spherical or ellipsoidal body. The artificial implant according to claim 10 ,
The artificial implant, wherein the radial expansion width of the at least one expandable element is substantially constant. The artificial implant according to claim 10 ,
The artificial implant wherein the radial expansion width of the at least one expandable element is variable. The artificial implant according to claim 1,
The artificial implant wherein the at least one inflatable element has a maximum expansion thickness that is less than a maximum diameter of the generally spherical or ellipsoidal body. The artificial implant according to claim 13 ,
The prosthetic implant, wherein the inflated thickness of the at least one inflatable element is substantially constant. The artificial implant according to claim 13 ,
The prosthetic implant, wherein the inflated thickness of the at least one inflatable element is variable. The artificial implant according to claim 1,
The artificial implant wherein the at least one expandable element is expandable radially outward along a substantially constant axis from the generally spherical or ellipsoidal body. The artificial implant according to claim 1,
The artificial implant wherein the at least one expandable element is expandable radially outward from the generally spherical or ellipsoidal body at an angle offset from a substantially constant axis. The artificial implant according to claim 1,
The artificial implant wherein the at least one inflatable element has an inflated thickness that differs between a location near the substantially spherical or ellipsoidal body and a location far from the substantially spherical or ellipsoidal body. The artificial implant according to claim 18 ,
The artificial implant wherein the at least one inflatable element includes at least one tapered edge in the inflated state. The artificial implant according to claim 1,
The artificial implant, wherein the at least one inflatable element and the generally spherical or ellipsoidal body are formed of at least one different material. The artificial implant according to claim 1,
The substantially spherical or ellipsoidal body includes two hemispherical or two quasi-hemispherical parts;
The artificial implant, wherein the at least one inflatable element is disposed between the two hemispherical or two quasi-hemispherical portions. The artificial graft according to claim 21 ,
The two hemispherical or two quasi-hemispherical portions of the generally spherical or ellipsoidal body maintain a tensile load of at least about 2268.0 g (about 5 pounds) without substantial deformation. An artificial graft that has been formed. The artificial implant according to claim 1,
The prosthetic implant, wherein the at least one inflatable element comprises an elastic material at least prior to inflation of the at least one inflatable element. The artificial graft according to claim 21 ,
The prosthetic implant, wherein the at least one inflatable element comprises an elastic material at least prior to inflation of the at least one inflatable element. The artificial implant according to claim 23 ,
The prosthetic graft, wherein the elastic material includes an inflatable bladder. The artificial implant according to claim 25 ,
The prosthetic implant, wherein the inflatable bladder is at least partially curable. The artificial implant according to claim 25 ,
The prosthetic implant, wherein the inflatable bladder includes at least one fluid or malleable material that is at least partially curable. The artificial implant according to claim 23 ,
The elastic material includes an inflatable wall disposed at least partially between the two hemispherical or two quasi-hemispherical portions of the generally spherical or ellipsoidal body. . The artificial implant of claim 28 ,
The prosthetic implant, wherein the expandable wall at least partially retains at least one fluid or malleable material that is at least partially curable. The artificial implant according to claim 1,
The prosthetic implant, wherein the expandable element comprises at least one fluid or malleable material that is at least partially curable. The artificial implant according to claim 1,
The prosthetic implant, wherein the generally spherical or ellipsoidal body includes at least one cavity. 32. The artificial implant of claim 31 wherein
A prosthetic implant wherein a volume that is free of most of the substantially spherical or ellipsoidal body includes the at least one cavity. The artificial implant according to claim 1,
At least a portion is substantially smooth, artificial implants of the outer surface of the body of the generally spherical or ellipsoidal. The artificial implant according to claim 1,
At least a portion is not substantially smooth, artificial implants of the outer surface of the body of the generally spherical or ellipsoidal. The artificial implant according to claim 1,
The outer surface at least partially biologically active material of the body of the generally spherical or ellipsoidal, and is coated with a biologically neutral material, or combinations thereof, artificial grafts. The artificial implant according to claim 1,
An artificial implant wherein the generally spherical or ellipsoidal body includes at least one opening. The artificial implant of claim 36 .
The artificial implant wherein the at least one opening is at least partially filled with a bioactive material, a bioneutral material, or a combination thereof. The artificial implant of claim 36 .
The at least one opening includes a connector that receives an element of the stabilization system to receive an instrument for guiding the prosthesis between adjacent vertebrae of the spine. Or an artificial graft that is adapted for a combination thereof. The artificial implant of claim 36 .
An artificial implant that includes a cap for at least partially covering or sealing the at least one opening. The artificial implant according to claim 1,
The substantially spherical or ellipsoidal body includes an artificial implant that includes a shape memory material. The artificial implant according to claim 1,
The artificial implant, wherein the at least one inflatable element comprises a shape memory material. The artificial implant according to claim 1,
The prosthetic implant, wherein the generally spherical or ellipsoidal body includes at least one electrical connection. The artificial implant according to claim 1,
The artificial implant, wherein the at least one inflatable element includes at least one electrical connection. The artificial implant according to claim 1,
An artificial implant wherein the generally spherical or ellipsoidal body includes at least one pressure sensor. The artificial implant according to claim 1,
The prosthetic implant, wherein the inflatable element includes at least one pressure sensor.

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